OPEP Device for Asthma
(AeroMUC Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: St. Joseph's Healthcare Hamilton

No Placebo Group

Trial Summary

What is the purpose of this trial?The goal of this randomized clinical trial is to evaluate the effect of daily AerobikaTM Oscillating Positive Expiratory Pressure (OPEP) device use on mucus plugging and airway function in adult patients with moderate-to-severe asthma.

Eligibility Criteria

Adults with moderate-to-severe asthma, diagnosed over a year ago and meeting specific criteria like an ACQ score above 1.5, certain levels of eosinophils or nitric oxide in their breath, and a CT mucus score over 4. They must be on a stable dose of inhaled corticosteroids and can't have other major lung diseases or recent substance abuse.

Inclusion Criteria

I am taking a high dose of inhaled corticosteroids or have been on prednisone or a biologic for over 3 months.

Your asthma symptoms are not well controlled during the screening period.

I am 18 years old or older.

+5 more

Exclusion Criteria

I've had an asthma attack treated with steroids in the last 6 weeks.

I have a device or metal in my body that cannot be removed.

I have not needed treatment for other lung diseases in the last year.

+7 more

Participant Groups

The trial is testing if using the Aerobika OPEP device daily improves mucus clearance and airflow in adults with serious asthma. Participants are randomly chosen to either use the device or not, allowing researchers to compare outcomes between the two groups.

2Treatment groups

Active Control

Group I: Aerobika OPEP deviceActive Control1 Intervention

The OPEP system (Aerobika®) combines positive expiratory pressure therapy and airway vibrations to help mobilize pulmonary secretions. OPEP therapy (Aerobika ®) enforces resistance to exhalation at the mouth, while the airway vibration technology transmits movements upstream during exhalation so that airway walls may become free from mucus. Participants will take home the device and use it twice daily for 16 weeks.

Group II: Standard of careActive Control1 Intervention

Standard of care management for 16 weeks.